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Norm
ÖNORM EN ISO 11197
Issue date: 2016 10 01
Medical supply units (ISO 11197:2016)
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL SUPPLY UNITS, NT.
hereafter also referred to as ME EQUIPME
This Internation...
Withdrawn: 2020 05 01
§ Legal References
Publisher:
Austrian Standards International
Format:
Digital | 35 Pages
Language:
German
| English
| Download GER/ENG
Currently valid:
Optionally co-design standards:
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL SUPPLY UNITS, NT.
hereafter also referred to as ME EQUIPME
This International Standard applies to MEDICAL SUPPLY UNITS manufactured within a factory or assembled on site, including cabinetry and other ENCLOSURES, which incorporate PATIENT care services.
HAZARDS inherent in the intended function of ME EQUIPMENT or ME SYSTEMS within the scope of this International Standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of IEC 60601-1:2005+A1:2012.
The object of this International Standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for MEDICAL SUPPLY UNITS as defined in 201.3.103.
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